Thermal contrast therapy device

ABSTRACT

Methods and apparatus for an improved Contrast Therapy Device that delivers alternating heated and chilled temperature fluids to a contrast thermal therapy pad. Mitigation processes maintain water temperature in hot water tanks and cold water tanks in order to keep water temperatures in the respective tanks from drifting beyond a desired setpoint range when the system switches a therapy state from a cooling cycle to a heating cycle or from heating cycle to a cooling cycle. Thermal shock is reduced to the fluid tanks. Mitigation techniques include delaying actuation of a return path flow, such as via a diverting solenoid. Mitigating delay can be a static time delay based upon one or both of: a volume of water in a therapy pad and related volume and rate of flow; and meeting a threshold transition temperature for return fluid temperature.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/204,405, titled “THERMAL CONTRAST THERAPY DEVICE”, filed on Mar. 17,2021, which in turn claimed priority to U.S. Non Provisional patentapplication Ser. No. 15/867,238 titled “ACCELERATED TRANSITION THERMALCONTRAST THERAPY DEVICE”, filed on Jan. 10, 2018, which in turn claimedthe benefit of U.S. Provisional Patent Application Ser. No. 62/444,416,titled “ACCELERATED TRANSITION THERMAL CONTRAST THERAPY DEVICE”, filedon Jan. 10, 2017, the entire content of each of which is herebyincorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a thermal device and system for therapyto biological tissue. The apparatus and methods disclosed herein providefor improved accelerated transitions between a heating cycle and coolingcycle applied to biological tissue by way of a hydraulic pad placed inthermal proximity to tissue being treated, as well as compression oftissue being treated based upon controlled variation of a fluid pressurewithin the hydraulic pads in thermal proximity to an area of treatedbiological tissue.

BACKGROUND OF THE INVENTION

Studies have shown that cooling and heating, along with cyclicalcompression, can speed muscle recovery after strenuous activity. Inthermal therapy applications, there is a need to precisely controltemperatures in microenvironments. Conventional cooling devices employedeither ice baths or the evaporation and condensation of gases, such aschlorofluorocarbon (CFC) and hydrochlorofluorocarbon (HCFC) to transferheat. However, these substances are not environmentally friendly, asthey are known to damage the earth's ozone layer and have a high globalwarming potential that can be thousands of times the potential of carbondioxide. Accordingly, solid state cooling systems were developed thatallow production of small commercial packages that are capable ofprecise temperature control in a variety of applications. Further, thesolid state cooling systems reduce energy usage considerably, therebyproviding additional cost-savings to users.

Currently, many trainers and therapists use ice wraps for cooling andheated hydroculator pads for heating. The problem with these methods isthe lack of temperature control. The ideal temperature for coolingmuscles and joints is 5-10° C. and for heating it is 45-48° C. Ice ismuch colder than this, typically coming out of a freezer at −18C andwarming to 0° C. when melting, cold enough to cause frostbite if enoughlayers of fabric are not placed between the patient's skin and the ice.Hydroculators recommended set points are 160-165° F., 71-74° C.,(Chattanooga Hydroculator M2 manual set point range), way above the 49°C. maximum temperature skin should come in contact with. As a result,hot and cold therapy injuries are common because users often fail toplace enough layers of insulating fabric between the skin and thewrap/pad.

Thermal contrast therapy devices have been known to use a singlereservoir from which fluid is withdrawn and either heated or cooled.These solid state cooling systems employ fluids to transfer heat frommicroenvironments that require temperature control. However, currentlyavailable systems suffer from several drawbacks, including thefollowing: a) the known systems do not rapidly transition betweenheating and cooling. The lack of rapid transition greatly lengthens thetime required for therapy, and may reduce therapeutic effectiveness; b)known systems such as the '914 patent use compressed air to providecompression. The air compressors used are cumbersome, noisy and may beirritating to a user; c) the known systems are designed to be carriedover a patient's shoulder, which is conspicuous to nearby persons. Forpatients desiring anonymity when requiring therapy (e.g., professionalathletes), such conspicuousness can be a significant detriment; d)unless frequently cleaned (or unless toxic coolants are used) the knownsystems allow bacteria and other microbes to grow in fluid channels ofcurrent systems, creating a potential health hazard.

SUMMARY OF THE INVENTION

Accordingly, the present invention provides methods and apparatus for animproved Contrast Therapy Device that delivers alternating heated andchilled temperature fluids to a contrast therapy pad that is placed inthermal proximity to tissue being treated. The improved methods andapparatus include mitigation processes that are deployed to maintainrespective fluid temperatures in a separate heated fluid storage tankand chilled fluid storage tank for controlled circulation through athermal therapy pad; and efficient drainage of a thermal therapy pad forstorage while not in use. Fluid stored in a storage tank and circulatedthrough a thermal therapy pad may include, for example, an aqueoussolution.

The mitigation processes used to maintain respective water temperaturesreduce thermal shock to a fluid storage tank resulting from a systemswitching a therapy state of a contrast therapy pad from a cooling cycleto a heating cycle, or from heating cycle to a cooling cycle. Theapparatus and methods of the improved contrast therapy system keep watertemperatures in a respective heated fluid storage tank and a chilledfluid storage tank from drifting outside of threshold setpoint rangesdesired for each fluid storage tank.

Methods and apparatus presented herein for reducing thermal shock to arespective fluid storage tank include delaying actuation of a returnpath flow, such as via a diverting solenoid. This delay can be a statictime delay based upon one or more of: a volume of fluid in a therapypad; a related volume and rate of flow of circulated fluid; and athreshold transition temperature for return fluid temperature being met.

The present invention, overcomes the shortcomings noted above, by use ofa flexible apparatus to provide a fast transition thermal therapy tobiological tissue with predefined temperature and pressure cycles,temperature controlled fluids, and pressurized wraps. Various featuresand embodiments are further described in the following figures,drawings, and claims.

One general aspect of the present invention includes a contrast therapyapparatus to provide controlled therapeutic treatments via a thermal paddelivering one or more cycles of thermal conditions to a body part. Theapparatus may include a thermal pad or other fluid delivery mechanismwith a fluidic channel having an input port and an output port; and athermally-transmissive outer covering. The contrast therapy apparatusmay also include a control unit, including: a fluid channel output portcoupled to the input port of the thermal pad fluidic channel; a fluidchannel input port coupled to the output port of the thermal pad fluidicchannel; a hot-fluid circulation loop coupled to the output port and theinput port; a cold-fluid circulation loop coupled to the output port andthe input port; a hot-fluid reservoir coupled to the hot-fluidcirculation loop, to hold hot fluid to be circulated in the hot-fluidcirculation loop; a cold-fluid reservoir coupled to the cold-fluidcirculation loop, to hold cold fluid to be circulated in the cold-fluidcirculation loop; a pump to provide fluid flow in at least one of thehot-fluid circulation loop and the cold-fluid circulation loop; atemperature sensor; a processor coupled to a memory, the processorconfigured to execute instructions stored in the memory, to provide tothe thermal pad a fluid flow having a predetermined temperature profile;and one or more diverting valves operative to cause the hot fluid toflow out of the hot reservoir and into the thermal pad, and flow out ofthe thermal pad into a cold fluid reservoir during a cold to hottransition delay period, and the hot fluid to flow out of the hotreservoir and into the thermal pad, and flow out of the thermal pad intothe hot fluid reservoir during a hot cycle that follows the cold to hottransition delay period.

Various implementations and embodiments may include one or more of thefollowing features. The contrast therapy apparatus may further includeseparate pumps for the hot-fluid circulation loop and the cold-fluidcirculation loop. One or more diverting valves may include one or morehot valves to couple the hot-fluid circulation loop to the therapy padand one or more cold valves to couple the cold-fluid circulation loop tothe therapy pad, said one or more hot valves and one or more cold valvesoperative to cause the cold fluid to flow out of the cold reservoir andinto the thermal pad, and flow out of the thermal pad into the hot fluidreservoir during a hot to cold transition delay period, and the coldfluid to flow out of the cold reservoir and into the thermal pad, andflow out of the thermal pad into the cold fluid reservoir during a coldthermal cycle which follows the hot to cold transition delay period. Aflow of cold fluid may progress out of the cold reservoir and into thethermal pad, and flow out of the thermal pad into the hot fluidreservoir during a hot to cold transition delay period improves thestability of the cold fluid reservoir during a cold thermal cycle byreducing a change of temperature change in the cold fluid reservoir ascompared to a change in temperature in the cold fluid reservoir withouta transition delay period including returning fluid from the cold fluidreservoir into the hot fluid reservoir. One or both of the hottransition delay period and the cold transition delay period may bebased upon a size of the thermal pad. A delay period includes between 5seconds and 90 seconds. and preferably includes a delay period ofbetween 15 seconds and 40 seconds.

In some embodiments, a flow rate of fluid through the thermal pad may bebetween about 0.5 to 2 liters per minute, and some preferred embodimentsmay include a flow rate of fluid through the thermal pad of betweenabout 0.8 and 1.2 liters per minute.

Some embodiments may include a delay time determined by measuring areturning fluid temperature and actuating return side diverting valveswhen the measured return side temperature reaches a pre-determinedthreshold. The pre-determined threshold occurs when return sidetemperature changes in an amount of between about 2c and 20c from anormal return side treatment temperature. The pre-determined thresholdoccurs when return side temperature changes in an amount of betweenabout 7c and 13c from a normal return side treatment temperature. Thecontrast therapy apparatus where the delay period is determined bymeasuring temperature of returning fluid and actuating return sidediverting valves when the measured return side temperature change meetsa pre-determined rate of change. The pre-determined rate of change isbetween about 0.01 c/sec and 0.2 c/sec. The pre-determined rate ofchange is between about 0.01 c/sec and 2.0 c/sec. The pre-determinedrate of change is between about 0.5 c/sec and 1.5 c/sec.

One or both of the hot transition delay period and the cold transitiondelay period may be based upon a type of thermal pad through which fluidis circulated. A flow of hot fluid out of the hot reservoir and into thethermal pad, and flow out of the thermal pad into the cold fluidreservoir during a cold to hot transition delay period improvesstability of the hot fluid reservoir during a hot thermal cycle byreducing a change of temperature change in the hot fluid tank ascompared to a change in a temperature in the hot fluid tank without atransition delay period including returning fluid from the hot fluidtank into the cold fluid reservoir.

Some implementations may include a contrast therapy apparatus includinga solenoid valve at each end of therapy pad. The valves may be operativeto divert fluid from flowing to the thermal pad to flowing to a venturithat provides suction pressure to remove fluid from the wrap. Thecontrast therapy apparatus may additionally include tubing attached toeach valve, the tubing size including a inside diameter and a flow ratethrough the venturi is between about 1 liters per minute and 2 litersper minute. In some embodiments, a suction pressure generated maypreferably be between about 1 pound per second and 2 pounds per second.Aspects of various implementations of the described techniques mayinclude hardware, a method or process, or computer software.

BRIEF DESCRIPTION OF THE DRAWINGS

As presented herein, various embodiments of the present invention willbe described, followed by some specific examples of various componentsthat can be utilized to implement the embodiments. The followingdrawings facilitate the description of some embodiments of the presentinvention.

FIG. 1 illustrates at a relatively high level of abstraction a thermalcontrast therapy system according to some exemplary embodiments of thepresent invention.

FIG. 2 illustrates at a relatively lower level of abstraction a thermalcontrast therapy system according to some exemplary embodiments of thepresent invention.

FIG. 3 illustrates a functional block diagram of a controller for athermal contrast therapy system according to some exemplary embodimentsof the present invention.

FIG. 4 illustrates a smart device and user interface according to someembodiments of the present invention.

FIG. 5 illustrates method steps that may be implemented in someembodiments of the present invention.

FIG. 6 illustrates additional method steps that may be implemented insome embodiments of the present invention.

FIG. 7 illustrates a thermal contrast therapy pad according to anexemplary embodiment.

FIG. 8 illustrates a fluid circulation path in a thermal therapy systemaccording to the present invention during a cold state and duringtransition with no mitigation mechanism.

FIGS. 8A-8D illustrate exemplary states of fluid circulation in athermal therapy system according to the present invention through pathsa temperature therapy wrap pad.

FIGS. 9A-9D illustrate various aspects of a fluid tank according to someembodiments of the present invention.

FIG. 10 illustrates a graph of temperatures present in a fluid storagetank and a thermal therapy pad during a thermal contrast cycle withoutthe mitigation processes presented herein being utilized.

FIG. 10A illustrates a graph of temperatures present in a fluid storagetank and a thermal therapy pad during a thermal contrast cycle with timedelayed mitigation processes presented herein being utilized.

FIG. 11 illustrates a graph of temperatures present in a fluid storagetank and a thermal therapy pad during a thermal contrast cycle withtemperature threshold based delay mitigation processes presented hereinbeing utilized.

FIG. 12 illustrates methods for purging a thermal therapy wrap accordingto some embodiments of the present invention.

The headings used herein are for organizational purposes only and arenot meant to be used to limit the scope of the description or theclaims. As used throughout this application, the word “may” is used in apermissive sense (i.e., meaning having the potential to), rather thanthe mandatory sense (i.e., meaning must). Similarly, the words“include”, “including”, and “includes” mean including but not limitedto. To facilitate understanding, like reference numerals have been used,where possible, to designate like elements common to the figures.Optional portions of the figures may be illustrated using dashed ordotted lines, unless the context of usage indicates otherwise.

DETAILED DESCRIPTION

The present invention provides apparatus and methods for providing rapidthermal transition during thermal contrast therapy, and compressiontherapy for biological tissue. According to the present invention,thermal treatment is provided via a precisely controlled thermal fluidthat is circulated in thermal proximity to biological tissue beingtreated. A hydraulic wrap simultaneously provides compression to thebiological tissue receiving thermal treatment. Methods and apparatus foran improved Contrast Therapy Device that delivers alternating heated andchilled temperature fluids to a contrast thermal therapy pad. Mitigationprocesses maintain water temperature in hot water tanks and cold watertanks in order to keep water temperatures in the respective tanks fromdrifting beyond a desired setpoint range when the system switches atherapy state from a cooling cycle to a heating cycle or from heatingcycle to a cooling cycle. Thermal shock is reduced to the fluid tanks.Mitigation techniques include delaying actuation of a return path flow,such as via a diverting solenoid. This delay can be a static time delaybased upon one or both of: a volume of water in a therapy pad andrelated volume and rate of flow and/or meeting a threshold transitiontemperature for return fluid temperature.

In some embodiments, sensors may provide a feedback loop to ascertainone or more physical conditions associated with the thermal andcompression therapy. In some aspects, sensors quantify a condition beingexperienced by the treated tissue. Data generated by the sensors may bereceived by a controller which in turn provides a control command toapparatus providing one or both of: thermal energy to the thermal fluidbeing circulated in thermal proximity to the tissue and a pump provinghydraulic pressure within a compression wrap fixedly and removablyattached in an area surrounding the tissue being treated. Data generatedmay also be used to ascertain compliance with a prescribed protocol andmemorialize a time, date, and place of compliance with a thermalcontrast treatment protocol, as well as conditions of the compliance.

In some embodiments, a thermal contrast treatment protocol may be storedon a Smart Device and communicated to a controller for administration toa patient. In return, the controller may communicate back to the smartdevice, data descriptive of actual conditions experienced by a patient.A smart device may include, by way of non-limiting example, a mobilephone or tablet. The smart device may be equipped with GPS to ascertaina location, a clock to ascertain a time and date and near fieldcommunications, such as Bluetooth, WiFi, or ANT to communicate with thecontroller.

In another aspect, in some embodiments, multiple loops of thermal fluidmay be included within a wrap and one or more of the loops may circulatethermal fluid at a given time. Similarly, a same or different loop forfluid within the wrap may be used to contain hydraulic pressure that inturn creates a compression force to tissue around which the hydraulicwrap is fixedly and removably attached.

According to the present invention, in some embodiments, a samehydraulic loop is used to circulate heated fluid during a first intervaland chilled fluid during a second interval. In other embodiments, afirst loop and a second loop may circulate fluid based upon theactuation of disparate first and second pumps in order to precisely andquickly transition from a temperature presented via a first fluid loopand a second fluid loop.

The exemplary systems and methods of this disclosure will be describedin relation to software, firmware, modules, and associated hardware.However, to avoid unnecessarily obscuring the present disclosure, thefollowing description omits well-known structures, components anddevices that may be shown in block diagram form, are well known, or areotherwise summarized.

The present invention provides specific control to provide what anoperator deems is optimum healing parameters and avoidance of injuries.The apparatus as disclosed herein provides precise temperature controlat the skin, and also allows a thermal therapy wrap to be used to betemperature controlled and form-fitting to the body part being treated.The present invention also enables the ability to pump atemperature-controlled fluid through the wrap and providing good thermalcontact through form-fitting to the skin.

The heat transfer mechanism for wraps/pads to skin is primarily throughthermal conduction. The equation for calculating heat transfer through aflat surface via thermal conduction from Fourier's Law is as follows:

Q/A=k/L*DT

Where Q=heat transfer rate (watts)

-   -   a. A=area through which heat is transferred (meters²)    -   b. k=thermal conductivity of the material through which heat is        transferred (watts/meter ° K)    -   c. L=thickness of the material through which heat is transferred    -   d. DT=the temperature gradient across the material through which        the heat is transferred

When calculating heat transfer rates, where typically there are severallayers of “thermal resistance”, an electrical model is often used, wherethermal resistances Θ are substituted for electrical resistances. Forconduction, the thermal resistance Θ=L/K.

When several thermal resistances exist, the heat flux becomes

-   -   a. n

Q/A=[S(1/Θ)]⁻¹*(DT)

-   -   a. l    -   b. Where    -   C. n        -   i. (1/Θ=the sum of all layers (n) through which heat is            transferred, so for three layers this            -   1. would be (L_(1/)k₁+L_(2/)k₂+L₃ k₃)    -   d. Q/A=heat flux (heat transferred per unit area)

For a form-fitting wrap made from urethane coated Nylon such as SOFT TEXRF-200, the nylon is 0.28 mm thick. Nylon has a thermal conductivityk=0.25 w/m° K, so, the heat flux Q/A is:

Θ=[(0.2 mm/1000 mm/m)/(0.25w/m° K)]=0.0008° Km²/w

(The actual wrap contact area is much less than 1 square meter, and theskin and hair on the skin add additional resistance to heat transfer, sothe actual heat flux into the body is less.)

In some embodiments, a Terry cloth towel may be used against skin of apatient, a thickness of a towel may be for example, about 4-8 mm and thethermal resistance of moist cotton fabric of 0.2 w/mK (this value varieswith water content from 0.04-0.6) we calculate a heat flux of:

Θ=[(0.0002/0.25)+(0.004/0.2)]=0.02° Km²/w

Thus the thermal resistance of the form fitting wrap/pad isapproximately 1/25th that of the wrap with Terry cloth towel.

To calculate the overall heat flux, the heat transfer rate from thefluid flowing through the wrap/pad to the wrap/pad inner surface must beincluded.

The thermal resistance of flowing water over the inner surface of thewrap/pad depends upon the flow rate and the pad geometry, but is on theorder of 0.01° Km²/w. Thus, for a typical heating temperature gradientof 10° C. (37-47° C.)=10° C. (° K) between the inner wrap surfacetemperature and the skin, the heat flux can be estimated as follows:

For the formfitting wrap/pad: Q/A=(0.01+0.0008)⁻¹*(10)=930 w/m²

While for a non-formfitting pad: Q/A=(0.01+0.02)⁻¹*(10)=330 w/m²

The form-fitting pad has approximately 3 times the heat flux of thenon-formfitting pad with the Terry cloth towel. As a result, to achievethe same heating, the temperature gradient from the non-formfitting padto the skin must be three times greater, or 30° C. This is whyChattanooga recommends the Non-formfitting pad be heated to 71° C.,71-37=34° C. or about three times the temperature gradient.

The highest recommended temperature coming in contact with skin is 50°C., 71° C. can cause burns to skin, which is why injuries are common.Similar problems can occur when cooling with ice.

The present invention, the form-fitting wrap with fluid channels, seeksto prevent potential injuries by providing the same heating at muchlower temperatures, less than 50° C. for heating and above 5° C. forcooling.

In some embodiments, insulative Neoprene backing to provide bladdersupport that focuses the bladders expansion onto the patient's bodypart, maximizing contact efficiency. Neoprene or a like material with anability to match the body's contours is preferred. A localized mechanismfor focusing compression on specific areas of the pad/body may beincluded in some embodiments and may include a strap with a hook andloop connector, a corset type cinch, buttons, snaps, buckle or otherfastener may also be used.

Further, the examples disclosed are for exemplary purposes only andother examples may be employed in lieu of, or in combination with, theexamples disclosed. It should also be noted that the examples presentedherein should not be construed as limiting of the scope of embodimentsof the present disclosure, as other equally effective examples arepossible and likely. The scope of the invention is set forth in theissued claims and equivalents thereof.

As used herein, the term “module” refers generally to a logical sequenceor association of steps, processes or components. For example, asoftware module may comprise a set of associated routines or subroutineswithin a computer program. Alternatively, a module may comprise asubstantially self-contained hardware device. A module may also comprisea logical set of processes irrespective of any software or hardwareimplementation.

A module that performs a function also may be referred to as beingconfigured to perform the function, e.g., a data module that receivesdata also may be described as being configured to receive data.Configuration to perform a function may include, for example: providingand executing sets of computer code in a processor that performs thefunction; providing configuration parameters that control, limit, enableor disable capabilities of the module (e.g., setting a flag, settingpermissions, setting threshold levels used at decision points, etc.);providing or removing a physical connection, such as a jumper to selectan option, or to enable/disable an option; attaching a physicalcommunication link; enabling a wireless communication link; providingelectrical circuitry that is designed to perform the function withoutuse of a processor, such as by use of discrete components and/or non-CPUintegrated circuits; setting a value of an adjustable component (e.g., atunable resistance or capacitance, etc.), energizing a circuit thatperforms the function (e.g., providing power to a transceiver circuit inorder to receive data); providing the module in a physical size thatinherently performs the function (e.g., an RF antenna whose gain andoperating frequency range is determined or constrained by the physicalsize of the RF antenna, etc.), and so forth.

Aspects of the present disclosure may be embodied as a system, method orcomputer program product. Furthermore, aspects of the present disclosuremay take the form of a computer program product embodied in one or morecomputer readable medium(s) having computer readable program codeembodied thereon or stored within a memory.

The present disclosure relates to methods and apparatus for maintainingtemperature control of a body part. More specifically, the presentdisclosure presents methods and apparatus for a thermal contrast therapysystem, including circulating thermal fluid in loops or channels througha pad or other item placed in thermal proximity to an area of a personor other mammal to be treated with the thermal therapy.

In some desirable embodiments, a thermal therapy system includes thefollowing attributes: it provides rapid switching from heating with athermal therapy pad to cooling with a thermal therapy pad; it hasprogrammable temperature and time cycles for therapy provided throughthe thermal therapy pad, it provides cyclical compression withoutirritating noise associated with an air compressor; cyclical thermalcycling and compression is user programmable; it is lightweight enoughto be easily carried by a thermal therapy patient and may be carriedinconspicuously; and it includes a built-in sterilizer mechanism totreat its fluid loop(s).

In the following sections, detailed descriptions of examples and methodsof the disclosure are given. Description of both preferred andalternative examples, though thorough, are exemplary only, and it isunderstood that variations, modifications, and alterations may beapparent to those skilled in the art, and such variations,modifications, and alterations are within the scope of the presentinvention. It is therefore to be understood that any examples includedherein do not limit the broadness of the aspects of the underlyingdisclosure as defined by the claims.

FIG. 1 illustrates at a relatively high level of abstraction a ThermalContrast Therapy System 100 according to the present invention that isoperative to administer heating therapy; cooling therapy; and in someembodiments, pressure therapy. Thermal Contrast Therapy System 100includes a therapy pad 101 coupled to a Therapy Control Unit 103.Therapy pad 101 is illustrated affixed to a body portion 102, such as anarm (other body parts may also be treated with thermal therapy accordingto the present invention). Therapy pad 101 may be fashioned or adaptableto fit or conform to be placed in thermal proximity to a variety of bodyparts. For example, therapy pad 101 may be a wrap removably fixed inposition around a portion of a limb such as an arm (as illustrated inFIG. 1); leg; torso, foot, hand; neck, skull; or other body portion.Alternatively, therapy pad 101 may be a substantially flat pad andsuitable for removably fixing to a shoulder or a back. Still furtherembodiments include a therapy pad 101 that is cap-shaped to fit on thehead, boot shaped to fit over a foot, mitten shaped to fit over hand,and so forth. In some embodiments, therapy pad 101 may be flexible toaccommodate being placed over a joint such as a knee; elbow; or ankleand be able to flex as the joint is flexed.

Therapy pad 101 may be coupled to a body part either securely orloosely. For example, a secure coupling may use straps to couple therapypad 101 to a body portion 102 such as a lower back. A secure couplingmay include snaps or a hook and loop fastener such as Velcro™ if therapypad 101 is fashioned as a wrap around a limb. In other embodiments, atherapy pad 101 may be loosely coupled if it merely rests upon a bodypart, such as a cap-shaped therapy pad 101 that may be placed on a head,or a therapy pad 101 that may be draped over a shoulder, and so forth.In some embodiments, therapy pad 101 may be adapted to be held in placeby an external apparatus, e.g., if therapy pad 101 is placed inside abrace, or inside a compression sleeve, or the like.

Therapy Control Unit 103 may include a physical control module 104 thatprovides control via electrical current to one or more heating and/orcooling devices in thermal communication via fluid lines 107, 106 withtherapy pad 101. For example, Therapy Control Unit 103 may includeheaters and/or coolers to deliver a temperature-controlled fluid totherapy pad 101 (e.g., fluid line 106) and receive fluid returned fromtherapy pad 101 (e.g., via line 107). Therapy pad 101 may include aninternal fluidic channels and connectors coupling fluid line 106 to line107, such that a closed loop may be formed from fluid line 106, throughtherapy pad 101 and back to Therapy Control Unit 103 via fluid line 107.

In some embodiments, additional types of physical therapeutic conditionsmay be provided, such as a pressure stimulus delivered to the bodyportion 102 via therapy pad 101 and hydraulic pressure delivered viafluid line 106, e.g., by use of a pump 109 within the therapy controlmodule 103 and a valve 108. The pump 109 and valve 108 may be used tocreate pressure within the fluid lines 106 107. The increased pressuremay in turn cause increased compression force upon tissue in the bodyportion 102 around which the thermal pad 101 is secured. The increasedpressure may be accomplished via Therapy Control Unit 103 increasingpump 109 performance. For example, a pump 109 may be used to forceincreased fluid into fluid line 106 and thereby increase pressure in thefluid line 106.

In another aspect, a valve 108 may divert some fluid to return line 107and/or the valve 108 may partially close a return line 107 to preventfluid from returning and thereby increase pressure within the line.Either method alone or in cooperation may be used to increase aninternal pressure of fluid line 106, an internal pressure of line 107,and/or an internal pressure of a fluidic channel within therapy pad 101.If the internal fluidic channel is constructed from an expandablematerial, the channel would expand with pressure and the effect would beto deliver pressure to a wrapped body portion 102, via a hydraulicpressurized cuff.

Therapy Control Unit 103 further may include a sensor interface module113, which may be used to monitor the application of stimulus to therapypad 101. For example, if temperature-controlled stimulus is beingprovided to therapy pad 101, then sensor interface module 113 maymeasure one or both of: a temperature of therapy pad 101 and atemperature of a patient's body portion 102.

In some embodiments, pressure-controlled stimulus is provided via thetherapy pad 101. Pressure controlled stimulus may include compressionforce on a body portion 102 resulting from hydraulic force within thetherapy pad 101. Sensors 111 in communication with a sensor interfacemodule 113 may quantify an internal pressure of therapy pad 101 as adigital or analog value, and a logical feedback loop in control module104 may control pumps 109 and valves 108 to provide for a correct levelof hydraulic pressure within the therapy pad 102 to apply acorresponding correct amount of compression to the body portion 102.

In some embodiments, a pressure transducer 110 may determine an amountof pressure against a body portion 102 and a hydraulic or fluidicpressure may be adjusted to bring the amount of pressure against thebody portion 102 in compliance with a prescribed protocol.

The feedback loop for applying compressive force against the body part102 and a surface temperature of the body part 102 may be created toperiodically or continually (no artificial delay) monitor conditionsexperienced by the body portion 102. The therapy control unit 103 mayadjust pressure and/or temperature provided by the Therapy Control Unit103 to the therapy pad 101 and thereby control conditions experienced bybody portion 102 such that conditions experienced by the body part willbe in compliance with a prescribed therapy protocol comprising thermaland pressure treatments for the body portion 102.

In some embodiments, temperature and/or pressure sensors 111 may beembedded within temperature therapy pad 101 in order to generate dataquantifying physical conditions experienced by the body portion 102. Thesensor 111 data may be accessed by the control module 104 for feedbackloops that executable software references to generate control commandsBy way of non-limiting example, control commands may include one or bothof digital and analog electrical currents. Conditions quantified by thesensors 111 may be stored in a memory and referenced for reporting oftemperature and pressure conditions experienced during a treatmentsession.

In some embodiments, a liner 112, such as a sleeve (or other shape) mayinclude one or more sensors 111. The liner 112 may be positioned under atherapeutic wrap 102 in order to take measurements closer to the skin.In some embodiments, a liner 112 may be held in place with a removableattachment device, such as hook and loop, adhesive, snaps, buttons, andthe like. Sensors or their liners 112 may be used with a thermalcontrast therapy system 100, and may be retrofitted to existing units.Sensors 111 may integrate a feedback loop to control a specific device,e.g., a temperature sensor may be used to control a heater. Someembodiments, include a liner 112 that is not limited to a particularwrap type such that the liner 112 may be used with a variety of thermalcontrast therapy systems 100 and liners 112. Feedback in the form ofdata provided by the liner 112 and the sensors 111 may be used togenerate control commands for components of the therapy control system100, such as pumps 109, valves 108, thermoelectric units, heaters andchillers.

Some embodiments incudes sensors 111 and/or liners 112 that aredisposable. Disposability helps ensure that the sensors 111 and/or theirliners 112 are sterile or at least clean of biological traces of aprevious usage. Sensors 111 and/or their liners 112 may also be designedto help guard the relatively more expensive wrap from direct exposure orcontact with biological tissue thus limiting transference of an adversecondition from a first patient to a second patient via use of the wrap.

Sensors 111 and/or their liners 112 may include a unique ID (e.g., abarcode, a hash code, an RFID code, etc.) associated with the patientand/or treatment. Sensors or their liners 112 may include removablestorage for the generated data, and may include a wireless communicationinterface (e.g., Bluetooth, Near Field Communications) to a user devicefor data transfer.

Therapy Control Unit 103 further may include a controller 105 (see FIG.3) or other device with a digital processor to execute a control programstored within a memory (not illustrated in FIG. 1) coupled to controller105. For example, controller 105 may be programmed to provide atemperature-controlled therapy to therapy pad 101, according to apredetermined time versus temperature profile. The predetermined profilemay be selected based upon an expected therapeutic benefit. In thisexample, controller 105 dynamically may control physical control module104 to provide a fluid at a controlled temperature to therapy pad 101,and a measured feedback temperature may be received by sensor interfacemodule 113 via data conduit 109. Controller 105 may also adjust controlmodule 104 in order to minimize a deviation of measured feedbacktemperature and/or pressure to correlate with a predetermined time andtreatment profile.

A predetermined time versus a treatment profile may include control overone or more of: the number of cycles between hot and cold temperatures;a hot temperature; a cold temperature; a time spent at hot temperature;a time spent at cold temperature; a transition time and/or rate betweenhot and cold; a shape of cyclical transitions (e.g., like a sinusoid orlike a square wave); relative ratios between hot and cold; flow rates(e.g., milliliters per second) of hot and cold; and so forth. In someembodiments, a predetermined time versus temperature profile may includeonly cycles of heating, or only cycles of cooling.

Fluid lines 106, 107 and/or data conduit may include electrical or lightbased data conductors to control elements within therapy pad 101, asdiscussed below in further detail in connection with FIG. 2.

Therapy pad 101 may be constructed from a flexible material that canconform at least partially to a body shape, e.g., by being wrappedaround a limb or to fit snugly on a scalp. However, therapy pad 101 alsomay include a minimum level of stiffness in order to prevent pinching ofinternal fluidic channels. Therapy pad 101 may include a protectiveouter layer in order to protect internal fluidic channels from puncturedamage or the like. Therapy pad 101 also may include an outer surfacetexture or material that is comfortable (or at least not uncomfortable)to human touch. The outer layer also should have high thermaltransmissibility.

FIG. 2 illustrates at a relatively lower level of abstraction a ThermalContrast Therapy System 200 to administer heating, cooling, and/orpressure therapy in accordance with some embodiment of the presentdisclosure. Components of Thermal Contrast Therapy System 200 areinterconnected as shown in FIG. 2. Thermal Contrast Therapy System 200includes electronic controller 202, which may correspond functionally toTherapy Control Unit 103 of FIG. 1. Thermal Contrast Therapy System 200also may include thermal therapy pad 201 (similar to therapy pad 101 ofFIG. 1), a plurality of telemetric sensing or monitoring devices 204 a .. . 204 f (collectively, monitoring devices 204), and a plurality ofcontrol devices 203 a . . . 203 f (collectively, control devices 203).An individual but nonspecific monitoring device or control device may bereferred to as a monitoring device 204 or a control device 203,respectively. FIG. 2 omits certain well-known features such as AC and/orDC power distribution.

A pair of fluidic lines 208 a, 208 b (collectively, fluidic lines 208)couple thermal therapy pad 201 to other components of Thermal ContrastTherapy System 200. One of fluidic lines 208 a, 208 b may be an inputline, and the other of fluidic lines 208 a, 208 b may be an output line.Fluidic lines 208 a, 208 b may be flexible and have a length of up toseveral feet, in order for thermal therapy pad 201 to be located a shortdistance from the other components of Thermal Contrast Therapy System200. For example, the other components of Thermal Contrast TherapySystem 200 may be carried by a person (e.g., on a belt, in a backpack,in a “fanny pack”, etc.), or be located a short distance away (e.g., ona table or equipment cart within about 5 feet of the person), whilestill allowing thermal therapy pad 201 to be positioned substantiallyanywhere on the person.

In some embodiments, Thermal Contrast Therapy System 200 may be operableeither from an AC line voltage or from a direct current power source,such as a battery power. A target minimum operating time on batterypower is preferably one hour.

Thermal Contrast Therapy System 200 further may include a hot fluidicline 209 a, 209 b (including its return, collectively hot fluidic lines209) and a cold fluidic line 210 a, 210 b (including its return,collectively cold fluidic lines 210). A set of valves 211 a may be usedto control whether or not hot fluidic lines 209 are operationallycoupled to fluidic lines 208. A similar set of valves 211 b may controlwhether or not cold fluidic lines 210 are operationally coupled tofluidic lines 208. Hot fluidic lines 209 couple together hot fluidreservoir 207 and hot pump 206 a. Cold fluidic lines 210 couple togethercold fluid reservoir 205 and hot pump 206 a.

Thermal Contrast Therapy System 200 further may include electroniccontroller 202. Electronic controller 202 may include several telemetricmonitoring devices 204 a . . . 204 f (collectively, monitoring devices204). Examples of monitoring devices 204 include temperaturemeasurements of temperature sensitive or controlled elements such asfluidic lines 209, 210, thermoelectric (“TEC”) heat exchangers 209 a,209 b, and levels of reservoirs 205, 207.

Based upon a desired stimulus profile and measurements from monitoringdevices 204, electronic controller 202 may provide control devices 203 a. . . 203 f (collectively, control devices 203) to the remainder ofThermal Contrast Therapy System 200, in order to provide a desiredstimulus to thermal therapy pad 201. Examples of control devices 203include valve controls 203 c, 203 d, power control 203 a, 203 e and pumpcontrols 203 b, 203 f.

Some exemplary embodiments include an arrangement of valves 211 a-b andpumps 206 a-b as described in the drawings. In particular, a specificarrangement of v valves 211 a-b and pumps 206 a-b to form a feedbackloop maintaining temperature levels and facilitating acceleratedtransition of thermal fluid applied to treated area.

According to the present invention fluid control devices, including, forexample, an arrangement of valves 211 a-b and pumps 206 a-b and fluidlines 210 a-b, may be made operative to apply thermal fluid hydraulicpressure to cuff and/or wrap pressure without need for air pressure andassociated pneumatic tubing. Furthermore, in some embodiments hydraulicpressure in lines 210 a-b may be applied together with pneumaticpressure. Features and benefits include reduced size of the controlunit, reduced noise level, cyclical compression without irritatingnoise, and simpler control units with no separate air channels.

In some embodiments, pressure from air or other gas may be generatedwithin fluid lines that are not being used to provide thermallycontrolled fluid during a particular cycle. For example, air pressuremay be provided in chilled fluid line 210 b during circulation of heatedfluid in a separate heated fluid lines 210 a. Compressed air in a linemay be used to flush cold fluid out of the line and may additionallyprovide compressive pressure of the wrap around a treated body part.Alternatively, air pressure may be used to flush hot fluid out of aheated fluid line 210 a. In this manner air may flush a first fluidprior to circulation of a second fluid. Still further, in someembodiments, an antimicrobial or disinfecting or cleansing solutionand/or gas may also be circulated in a chilled fluid line 210 b or aheated fluid line 210 a when not being used to convey thermallycontrolled fluid. Note: this would require two separate sets of fluidlines in the pad, not shown anywhere.

Embodiments in accordance with the present disclosure may controlThermal Contrast Therapy System 100 and/or Thermal Contrast TherapySystem 200 to provide a prescribed or desired therapy, including acontrolled variation over time of the therapy. For example, prescribedvariations of therapy may include at least one heated fluid line (e.g.,hot fluidic lines 210 a) and one chilled fluid line (e.g., cold fluidicline 210 b), which together may provide sequentially alternating hot andcold therapy to thermal therapy pad 201 via alternating supply fromfluid lines 210 a and 210 b via control valves 211 a and 211 brespectively. Some embodiments may provide additional temperaturecontrolled loops and/or an unequal number of temperature controlledloops, such as two or more chilled fluid loops, two or more heated fluidloops, and so forth.

The present invention provides for thermally controlled fluid stored ina hot fluid reservoir 207 and cold fluid reservoir 205 is an improvementover the previous systems that are based upon a single shared reservoirto supply fluid that in turn is either heated or cooled. An equilibriumtemperature of the single shared reservoir in the '614 patent will benear the center of the temperature difference between hot fluid and coldfluid weighted by the ratio of hot versus cold fluid used. In contrast,separate reservoirs included in the present application allow for aheated fluid reservoir 207 and chilled fluid reservoir 205 to maintainrespective separate equilibrium temperatures, each respectiveequilibrium temperature is maintained closer to a respective temperatureof hot or cold fluid when applied as therapy in thermal therapy pad 201.This means that less heating by thermal electric unit 209 a or coolingby thermal electric unit 209 b is required of the fluids drawn from hotfluid reservoir 207 or cold fluid reservoir 205. Accordingly, fewerjoules of heat need to be added to hot fluid, or joules of heat removedfrom cold fluid. In turn, this means that TEUs 209 a, 209 b may haveattributes that allow them to be one or more of: smaller, less costly,draw less electrical power, and/or operate more quickly to bring fluidtemperature to a required therapy temperature for thermal therapy pad201, compared to usage of a single shared fluid reservoir in thebackground art.

Another advantage of the present invention includes switching of a setof hot valves 211 a and a set of cold valves 211 b may be sequencedand/or timed in a process that can control a flow and/or volume ofthermal control fluid in a loop during use and while not being usedduring a specified period of time.

For example, when a heating, hot fluidic lines 210 a is active and aflow of fluid in cold line 210 b is reduced. This provides severalbenefits compared to a single reservoir system of the background art.For example, unlike the background art, energy is not wasted by thethermal conditions in the respective loops not competing with eachother. During a heat cycle valves may dictate that only heat iscirculated through a thermal pad, and during a cooling cycle, only coolfluid is circulated through the thermal pad. In addition, in anancillary aspect, repeatedly heating and cooling the valves themselvesand the walls of dedicated lines 209 b, 210 b may be minimized viacontrol of the valves. The temperature of fluid delivered to thermaltherapy pad 201 can be changed more quickly since there is less hotfluid needing to be cleared from the lines when cold therapy is nowdesired, and less cold fluid needing to be cleared from the lines whenhot therapy is now desired. For example, the temperature of fluiddelivered to temperature therapy pad 201 may be changed, full range ornear-full range, from a hot temperature to a cold temperature within10-25 seconds (or less with a high speed pump).

Embodiments in accordance with the present disclosure may include amanifold controlled by solenoid valves 211 a-211 b, in order to connectone or more thermal therapy pads 201 to fluid lines 210 a-b. Thesolenoid valves 211 a-211 b may be operated to provide rapid switchingbetween hot and cold fluids. In some embodiments, a valve timingsequence may be provided such that a return valve is closed later. Thesolenoids 212 a and 212 b may be provided in different configurations,such as six two-way solenoids, or two three-way and two two-waysolenoids, and so forth.

In some embodiments, separate pumps 206 a, 206 b may be associated witheach respective fluidic thermal lines 210 a, 210 b. Separate pumps 206a, 206 b may be useful to activate and to control more precisely thecirculation of the temperature-controlled fluid (e.g., if placed beforevalves 211 a, 211 b to control the combination of the fluid lines).Separate pumps 206 a, 206 b and appropriate valve configuration alsoallow each of fluidic thermal lines 210 a, 210 b to circulateindependently of each other, without entering thermal therapy pad 201,in order to better keep fluid in the respective reservoirs 205, 207 atthe respective desired temperatures. In other embodiments, a single pump206 a, 206 b may be provided after the valves 211 a, 211 b combining thehot and cold fluidic lines 210 a, 210 b. A single pump 206 a, 206 bconfiguration may be smaller, lighter, and less costly, but may requiremore complicated valving in order to alternate maintenance oftemperatures of reservoirs 205, 207.

Another advantage of the present application compared to the backgroundart is that pumps 206 a, 206 b may be used to increase pressure influidic lines 210 a, 210 b in order to deliver hydraulic pressure tothermal therapy pad 201 through connecting hoses 208 a and 208 b. Thehydraulic pressure may then cause thermal therapy pad 201 to expand andprovide pressure against body portion 102. In such embodiments, elementsproviding pressure also are delivering thermal therapy, thus offering apossibility of more efficient transfer of heat or cold to body portion102 by the combination of pressure and direct contact by thefluid-bearing elements within thermal therapy pad 201. In contrast, forthe background art that uses air and an air compressor to inflate a cuffaround a body part, such pneumatic methods do not necessarily provide anequivalent level of direct contact by the fluid-bearing elements withina thermal therapy pad 201.

Another advantage of the present application compared to previouslyknown systems, is that usage of separate pumps 206 a, 206 b enables lesscomplicated application of different pressure profiles of hot fluid andcold fluid, compared to a single pump configuration. For example, if itis desired that hot therapy should be delivered with 50% higher pressurethan cold therapy, then hot pump 206 a simply may be set to provide 50%more pressure than cold pump 206 b, and no dynamic pressure control isrequired for pumps 206 a, 206 b. In contrast, for a single pump system,pressure provided by the single pump must be dynamically controlled incoordination with the desired temperature therapy profile.

Reservoirs 205, 207 are useful to provide rapid transfer between hot andcold fluid, by helping reduce a temperature differential that the heaterand/or cooler need to provide. For example, if hot and cold fluid arealternately supplied to thermal therapy pad 201, then as fluid of onetemperature is supplied to thermal therapy pad 201 (e.g., hot fluid),then the fluid of the other temperature (e.g., the cold fluid) may berecirculated and placed in thermal contact with a thermal electric heatexchanger 209 a to help maintain a desired temperature.

As illustrated in FIG. 2, each of fluidic lines 210 a, 210 b may includea respective fluid reservoir 205, 207, with fluid level sensors, whichfeed one or more circulating pump(s). A temperature sensor may be usedto measure the respective fluid temperature of each of fluidic lines209, 210. Fluidic lines 210 a, 210 b allow temperature-controlled fluidto recirculate through itself and/or flow through the therapy pad.

In some embodiments, hot fluidic line 210 a may be in thermalcommunication with heaters (e.g., a thermoelectric 210 a or resistiveheater to control heated thermal fluid temperature within a range,typically ranging from about 40 degrees Celsius (“C”) to about 48degrees C. Cold fluidic thermal line 210 b may be in thermalcommunication with a cooler (e.g., a TEC cooler) to control its fluidtemperature within a range, typically ranging from about 2 degrees C. toabout 12 degrees Celsius.

In some embodiments, a fluidic line 210 a and 210 b each may circulatethermal fluid within itself or through thermal therapy pad 201 whencoupled to a person. Electronic controller 202 may modulate powerseparately to the heaters and coolers in order to control a respectivetemperature of each loop. Temperature control may be based upon aproportional-integral-derivative (“PID”) control algorithm and themeasured temperature of the respective fluidic line.

In some embodiments, electronic controller 202 or a secondary controller(not illustrated in FIG. 2) may control solenoid valves 211 a-211 b thatdirect the hot and cold circulating fluids either to the therapy pad orto recirculate within the loop.

In addition, cyclical compression as desired also may be provided. Forexample, a speed of one or more pumps 206 a-206 b may be varied ormodulated by use of the controller (i.e., either electronic controller202 or the secondary controller if present) to provide cyclicalcompression. A user or a therapy profile may specify a desired stimulusprofile of hot fluidic line 209 and cold fluidic line 210. For example,electronic controller 202 may be programmed to set respective desiredtemperatures of hot fluidic line 210 a and cold fluidic line 210 b; toset respective time periods that hot fluidic line 210 a and cold fluidicline 210 b circulate through thermal therapy pad 201, or recirculatewithout entering thermal therapy pad 201, or no circulation at all; toset a number of hot/cold cycles each treatment performs; and to set adesired compression cycle at each temperature.

In some embodiments, an integrated sterilizer 213 may sterilize fluidperiodically or continuously in each reservoir in order to preventbacteria growth. The sterilizer 213 may use technology such as anultraviolet (“UV”) light source (including an UV light emitting diode(“LED”)), or introduction of an ionized or reactive gas such as ozone,and so forth. The sterilizer 213 may be located in or more of thereservoirs 206, 207, and/or along fluidic lines 210 a, 210 b. At least aportion of reservoirs 206, 207, and/or fluidic lines 210 a, 210 b may bemade from a UV-transmissive material in order to pass UV light forsterilization.

In some embodiments, a log or record of measured temperatures in ThermalContrast Therapy System 200 and/or on the patient may be maintained forcontemporaneous or post-treatment analysis. For example, patienttemperatures may include a record of skin temperature during therapy.Temperatures measured, for example, via infrared probe, bimetal sensoror other sensor.

In some embodiments, temperature measured from a patient (e.g., thepatient's measured skin temperature) may be used as feedback to adjustoperating parameters of Thermal Contrast Therapy System 200. Forexample, if a sensor quantifying skin temperature indicates that apatient's skin temperature is too high relative to a desired therapeuticprofile, operation of Thermal Contrast Therapy System 200 may beadjusted to lower the temperature of hot fluidic line 210 a, or toreduce an amount of time that hot fluid is provided to thermal therapypad 201, or to increase the amount of time that cold fluid is providedto thermal therapy pad 201, or to reduce the ratio of hot/cold operatingtime, and so forth, including a combination of methods.

In some embodiments, Thermal Contrast Therapy System 200 may beconfigured to provide an auditable record of control system operation,such as treatment time and date, patient data (e.g., measured skintemperature during treatment), therapy data (e.g., some or all oftelemetric monitoring devices during treatment), compliance with adesired treatment profile, and so forth. In some embodiments, aninterface to a remote web-based or cloud-based computing platform may beprovided, at least to maintain the auditable record of control systemoperation.

In some embodiments, compression may be varied by varying a speed ofpumped thermal fluid. Pumped thermal fluid speed may be varied bytechniques such as: (a) controlling speed of the pump itself; (b) use ofa pressure control orifice to set pressure levels; and/or (c) use of apressure sensor to set pressure levels. At least some of these methodsdo not necessarily need to control speed of the pump itself. Sensors 214a-214 b to measure speed and/or pressure of the pumped fluid may includea piezoelectric sensor in thermal therapy pad 201, and/or a fluidpressure sensor.

FIG. 3 illustrates a functional block diagram of a controller 300 inaccordance with some embodiment of the present disclosure. Controller301 may be useful to implement embodiments of the present invention,e.g., usable to function as at least part of electronic controller 202.

Controller 301 may include a bus 302 or other communication mechanismfor communicating information, and a processor 303 coupled with bus 302for processing information. In some embodiments, bus 302 may representmore than one individual bus, e.g., a fast bus to access fast componentssuch as main memory 304 and Processor 303, and a separate relativelyslower bus to access slower components such as user interface devices(displays 307, 308, input device 309 and cursor control 310), storagedevice 306, and/or communication interface 311.

Controller 301 also includes a main memory 304, such as a random accessmemory (RAM) or other dynamic storage device, coupled to bus 302 forstoring information and instructions to be executed by microcontroller354. Main memory 304 may also be used for storing temporary variables orother intermediate information during execution of instructions to beexecuted by Processor 303. Controller 301 further includes a read onlymemory (ROM) 305 or other static storage device 306.

Controller 301 may be coupled via bus 302 to a display 307, such as alight emitting diode (LED) display, organic light-emitting diode (OLED),projector, or heads up display for displaying information to a computeruser. An input device 309, including alphanumeric and other keys, may becoupled to bus 302 for communicating information and command selectionsto Processor 303. Another type of user input device is cursor control310, such as a mouse, a trackball, a touchpad, or cursor direction keysfor communicating direction information and command selections toProcessor 303 and for controlling cursor movement on display 307.Another type of user input device is a touchscreen display 308 where auser may communicate information and command selections to Processor 303by tactile interaction with the display thereby controlling cursormovement or alphanumeric and other keys. This input device typically hastwo degrees of freedom in two axes, a first axis (e.g., x) and a secondaxis (e.g., y), that allows the device to specify positions in a plane.

Embodiments of the invention are related to the use of controller 301for setting operational parameters relating to operation of thermaltherapy pad 201. According to some embodiment of the invention, layeringsystem parameters are defined and managed by controller 301 in responseto Processor 303 executing one or more sequences of one or moreinstructions contained in main memory 304. Such instructions may be readinto main memory 304 from another computer-readable medium, such asstorage device 306. Execution of the sequences of instructions containedin main memory 304 causes Processor 303 to perform the process stepsdescribed herein. In alternative embodiments, hard-wired circuitry maybe used in place of or in combination with software instructions toimplement the invention. Thus, embodiments of the invention are notlimited to any specific combination of hardware circuitry and software.

The term “computer-readable medium” as used herein refers to any mediumthat participates in providing instructions to Processor 303 forexecution. Such a medium may take many forms, including but not limitedto, non-volatile media, volatile media, and transmission media.Non-volatile media includes, for example, a storage device 306 and ROM305. Volatile media includes dynamic memory, such as main memory 304.Transmission media includes coaxial cables, copper wire and fiberoptics, including the wires that comprise bus 302. Transmission mediamay also take the form of electromagnetic waves, such as those generatedby Bluetooth™ or WiFi and infrared data communications.

Common forms of computer-readable media include, for example, a SSD(solid state disk), a memory stick, hard disk or any other magneticmedium, a CD-ROM, any other optical medium, a RAM, a PROM, and EEPROM,any other memory chip or cartridge, or any other medium from which acomputer may read.

Various forms of computer readable media may be involved in carrying oneor more sequences of one or more instructions to Processor 303 forexecution. For example, the instructions may initially be carried on amagnetic disk of a remote computer. The remote computer may load theinstructions into its dynamic memory and send the instructions over adistributed network such as the Internet. A communication device mayreceive the data on the telephone line, cable line, or fiber-optic lineand use an infrared transmitter to convert the data to an infrared lightpattern corresponding with a logical value. An infrared detector mayreceive the data carried in the infrared light pattern and appropriatecircuitry may place the data on bus 302. Bus 302 carries the data tomain memory 304, from which Processor 303 retrieves and executes theinstructions. The instructions received by main memory 304 mayoptionally be stored on storage device 306 either before or afterexecution by Processor 303.

Controller 301 also includes a communication interface 311 coupled tobus 302. Communication interface 311 provides a two-way datacommunication coupling to a network link 312 that may be connected to alocal network 313. For example, communication interface 311 may operateaccording to the internet protocol. As another example, communicationinterface 311 may be a local area network (LAN) card allowing a datacommunication connection to a compatible LAN. Wireless links may also beimplemented. Network link 312 typically provides data communicationthrough one or more networks to other data devices. For example, networklink 312 provides a connection through local network 313 to a hostcomputer 314 or to data equipment operated by an Internet ServiceProvider (ISP) 315. ISP 315 in turn provides data communication servicesthrough the worldwide packet data communication network now commonlyreferred to as the “Internet” 316. Local network 313 and Internet 316both use electrical, electromagnetic or optical power values that carrydigital data logic. The power values through the various networks andthrough communication interface 311, carry the digital data to and fromcontroller 301 are exemplary forms of carrier waves transporting theinformation.

In some embodiments, Controller 301 may send messages and receive data,including program code, through the network(s), network link 312 andcommunication interface 311. In the Internet example, a server 317 mighttransmit a requested code for an application program through Internet316, ISP 315, local network 313 and communication interface 311.

Processor 303 may execute the received code as it is received, and/orstored in storage device 306, or other non-volatile storage for laterexecution. In this manner, controller 301 may obtain application code inthe form of a carrier wave.

Access devices may include any device capable of interacting withcontroller or other service provider. Some exemplary devices may includea mobile phone, a smart phone, a tablet, a netbook, a notebook computer,a laptop computer, a wearable computing or electronic device, aterminal, a kiosk or other type of automated apparatus. Additionalexemplary devices may include any device with a microcontrollerexecuting programmable commands to accomplish the steps describedherein.

A controller may be a programmable board such as an Arduino™ orRaspberry Pi™ microprocessor board, and/or one or more of: personalcomputers, laptops, pad devices, mobile phone devices and workstationslocated locally or at remote locations, but in communication with thesystem. System apparatus may include digital electronic circuitryincluded within computer hardware, firmware, software, or incombinations thereof. Additionally, aspects of the invention may beimplemented manually.

Apparatus of the invention may be implemented in a computer programproduct tangibly embodied in a machine-readable storage device forexecution by a programmable processor and method actions may beperformed by a programmable processor executing a program ofinstructions to perform functions of the invention by operating on inputdata and generating output. The present invention may be implementedadvantageously in one or more computer programs that are executable on aprogrammable system including at least one programmable processorcoupled to receive data and instructions from, and to transmit data andinstructions to, a data storage system, at least one input device, andat least one output device. Each computer program may be implemented ina high-level procedural or object oriented programming language, or inassembly or machine language if desired, and in any case, the languagemay be a compiled or interpreted language. Suitable microcontrollersinclude, by way of example, a processor and memory combination.

Generally, a processor will receive instructions and data from aread-only memory and/or a random access memory. Generally, a computerwill include one or more mass storage devices for storing data files;such devices include magnetic disks, such as internal hard disks andremovable disks magneto-optical disks and optical disks. Storage devicessuitable for tangibly embodying computer program instructions and datainclude all forms of non-volatile memory, including, by way of example,semiconductor memory devices, such as EEPROM and flash memory devices;magnetic disks such as, internal hard disks and removable disks; and CDROM disks. Any of the foregoing may be supplemented by, or incorporatedin, ASICs (application-specific integrated circuits).

In some embodiments, implementation of the features of the presentinvention is accomplished via digital computer utilizing uniquelydefined controlling logic, wherein the controller includes an integratednetwork between and among the various participants in ProcessInstruments.

The specific hardware configuration used is not particularly critical,as long as the processing power is adequate in terms of memory,information updating, order execution, redemption and issuance. Anynumber of commercially available database engines may allow forsubstantial account coverage and expansion. The controlling logic mayuse a language and compiler consistent with that on a CPU included inthe medical device. These selections will be set according to per sewell-known conventions in the software community.

Referring now to FIG. 4, a smart device 400 is illustrated with a humanreadable graphical user interface 400A. In some embodiments, a smartdevice 400 may be used to set parameters and protocols within a TherapyControl Unit 103 (not illustrated in FIG. 4). The smart device willtypically communicate via an embedded wireless device 401 that may use aform of near field communication (such as IEEE 802.15.1 known asBluetooth™, WiFi through a router, or IEEE 802.15.4 known as ZigBee™) tointeract with the Therapy Control Unit 103. Interactive user controls onthe smart device may set therapy protocols 403, process sensor readings404; identify a patient receiving therapy 405, or other functionality.In some embodiments, data 402 may be displayed for review by one or bothof: a therapy provider and a patient. The data may include, for example,sensor readings at specified time intervals.

In another aspect, a smart device 400 may include control modules thatallow for wireless control of one or more protocol parameters, such as:temperature settings 406; number of cycles and length of respectivecycles 407; and an amount of pressure 408 to accompany the respectivecycles. In addition, a cancel control 409 may reset the smart device appand a “send” control 410 may wirelessly send one or more of: sensorreadings 404, protocol parameters, date and time, location (via, forexample GPS), a user identifier (such as an alphanumeric universallyunique identifier UUID). The send button may communicate via a Wi-Fi,cellular network or other wireless platform.

Referring now to FIG. 5, method steps are presented that may be followedin whole or in part in various implementations of the present invention.At method step 500, a user or health care provider may input a therapyprotocol. The therapy protocol may be entered into a Therapy ControlUnit, or via a smart device. At method step 501, in some embodiment's atherapy protocol may be entered remotely and transmitted to a TherapyControl Unit digital transmission, such as via wireless communication,Bluetooth, a network, such as one or more of: the Internet, via acellular or wireless network and via near field communications.

At method step 502, a protocol temperature and length of time may beinput. At method step 503, a protocol pressure and length of time may beset.

At method step 504, a temperature and pressure specified for a protocolmay be coordinated. Coordination may include, for example, an amount ofpressure that will be applied while an amount of heat or cooling therapyis simultaneously applied.

At method step 505 a first pump may be activated to control circulationof a cooling fluid. At method step 505A a second pump may be activatedto control circulation of a heating fluid. One or both of method steps505, 505A may be performed, either in sequence, or at least partiallyconcurrently, or individually without the other of method steps 505,505A. At method step 506 a timer may be started to associate a time thata protocol step or cycle is administered and at method step 507 one ormore valves and pumps may be controlled to administer the therapyprotocol input.

At method step 508, the Therapy Control Unit may receive one or moresensor readings and at method step 509 the Therapy Control Unit mayadjust one or both of the cooling and heating loop based upon the sensorreadings received.

At method step 510, timing of one or both of a heating cycle and acooling cycle and an amount of pressure applied during the respectivecycles may be tracked in accordance with the protocol specifications.

At method 511, one or both of valves and pumps may be deactivated uponcompletion of the therapy protocol. Other method steps may be includedand variations of those steps described above are all within the scopeof the present invention.

Referring now to FIG. 6, additional method steps are listed that relateto aggregation of therapy treatment data and generation of therapyprotocols based upon the aggregated data. At method step 600 a user orhealth care practitioner or therapy practitioner may input conditiondescriptors and at method step 601 set a temperature and a pressureprotocol for a patient to receive. At method step 602 a patient may beadministered a temperature and pressure protocol.

At method step 603 data that is descriptive of conditions in proximityto a treated body part during a time of administration of an expeditedtransition temperature and pressure therapy protocol.

At method step 604, data generated during the administration of theexpedited transition temperature and pressure therapy is aggregated. Insome preferred embodiments the data may be aggregated across multipletreatments including one or multiple patients.

At method step 605, a new, fast transition temperature and pressureprotocol may be generated based upon the aggregated data and successpatterns for treatments.

FIG. 7 illustrates an alternative embodiment 700 of a temperaturetherapy pad 701. In particular, temperature therapy pad 701 is similarto temperature therapy pad 101 and/or thermal therapy pad 201, butfurther includes one or more integrated light therapy sources 703 (forsake of clarity, not all integrated light therapy sources are markedwith a reference number in FIG. 7). Light therapy also may be known asphototherapy or heliotherapy, and may include exposure to specificwavelengths or ranges of wavelengths of light that are expected toprovide a therapeutic benefit. The therapeutic benefit may include aproven clinical effect and/or a placebo benefit. The light may beadministered for a prescribed amount of time and/or time of day (e.g.,at night during sleep). Embodiments in accordance with the presentdisclosure combine light therapy with accelerated transition thermalcontrast therapy in order to provide a more com-pact device 701 that isable to deliver both types of therapy to the same body part, and deliverthe therapies simultaneously if desired.

Temperature therapy pad 701 includes one or more integrated lighttherapy sources 703 that deliver the therapeutic light. Light therapysources 703 are positioned in order to emit light toward a body partwhen temperature therapy pad 701 is attached to the body part.Temperature therapy pad 701 may differ from the depiction of FIG. 7,e.g., by usage of a different number of light therapy sources 703 ordifferent placement of light therapy sources 703. In some embodiments,light therapy sources 703 may be dynamically controlled to provide lightthat varies over time in intensity, wavelength, or other characteristic.The light therapy may be combined with temperature and pressure therapy,either sequentially or at least partially at the same time.

In some embodiments, operation of the light therapy sources 703 may becoordinated with delivery of temperature and/or pressure therapy bytemperature therapy pad 701. As such, one or more light therapy sources703 may emit light either: a) independent of a temperature conditionassociate with the wrap; b) independent of a pressure conditionassociated with the wrap; c) in combination with a specific lighttherapy state; d) in combination with a specific pressure state and incombination with both temperature and pressure state caused b, orotherwise associated with the wrap.

Referring now to FIG. 8, a block diagram illustrates a contrast therapypad 800 in thermal communication with a Cold Tank 801 and a Hot Tank 802via supply thermal fluid lines 806-807 and return fluid line 809. Avalve 809 (such as, for example, a threeway valve) is operative totoggle a flow of thermal fluid from return thermal fluid line 808 intoeither a cold tank return line 803 leading into a cold tank 801 or a hottank return line 804 leading into a hot tank 802. During the cold cycle800C, the valve 809 directs the flow of thermal fluid returning from thethermal therapy pad 810 into the cold tank return line 803 leading intocold tank 801. During transition 800T, the valve 809 switches the flowof thermal fluid returning from the thermal therapy pad 810 into the hottank return line 804 leading into a hot tank 802 with no artificialdelay in flow of the thermal fluid.

The graph illustrated in FIG. 10 quantifies a hot tank temperature 1002that dips as the return flow of thermal fluid is transitioned fromreturning to the cold tank 801 into the hot tank 802. At approximatelytime 0 to 10 seconds the hot tank temperature 1002 is approximately45.1° C. (hot tank set temperature) to approximately 40.6° C. from time(“T”)=10 seconds to T=50 seconds. The hot tank temperature 1002 does notreturn to hot tank set temperature of 45° C. until after a hot cycle forsupply of heated thermal fluid to the thermal pad 800 is complete andalmost halfway through the cold cycle (T=200 seconds). With nomitigation, the hot tank had a temperature of less than the hot tank settemperature 45° C. during the entire hot cycle (approximately T=25seconds to T=130 seconds). Two additional hot cycles (beginning at T=280seconds and T=500 seconds) shown on the graph indicate a similar result.

Referring now to FIGS. 8A-8C, block diagrams illustrate circulation ofheated or chilled thermal fluid through a temperature therapy pad 800and returned to either a cold tank return line 803 leading into a ColdTank 801 fluid reservoir or a hot tank return line 804 leading into aHot Tank 802 fluid reservoir.

As illustrated in FIG. 8A, during a temperature cycle circulatingchilled thermal fluid through a temperature therapy pad 800 (ColdCycle), the solenoid 809 directs fluid returning from the temperaturetherapy pad 800 (return fluid) to a Cold Tank 801 fluid reservoir. TheHot Tank 802 contains fluid that is kept at a raised temperature level(as compared to a temperature in the Cold Tank 801). The temperaturelevel of one or both of the hot thermal fluid and cold thermal fluid maybe set and maintained via one or more thermoelectric temperature controlunits 805 (sometimes referred to as a TEC). A temperature of one or moreof the return fluid, fluid in the Cold Tank 801 and fluid in the HotTank 802 may be measured via a temperature sensor 803.

FIGS. 8B-8C, illustrates a transition period during which a Cold Cycleis transitioned to a Hot Cycle. The transition period includes a periodof time to cycle a first thermal fluid, (in this example a chilledthermal fluid) out of the thermal therapy pad 800 and replace thethermal fluid in the thermal therapy pad 801 with a second thermal fluid(in this example a heated thermal fluid) such that the heated thermalfluid is directed to flow through the temperature therapy pad 800 for apredetermined period of time (Hot Cycle).

During a transition period from a Cold Cycle to a Hot Cycle, Hot Fluidis supplied into the Thermal Therapy Pad 800 from the Hot Tank 802. Atemperature of a return fluid from the Thermal Therapy Pad 800 may bemeasured via the temperature sensor 810. If the temperature measurementis below a threshold temperature specification, the return fluid isdirected via actuation of a solenoid 809 to the Cold Tank 801. As thereturn thermal fluid rises to a threshold Hot Cycle temperature, thereturn thermal fluid is directed via activation of the valve 809 back tothe Hot Tank 802.

During a transition period from a Hot Cycle to a Cold Cycle, a processis completed wherein Cold Thermal Fluid is supplied into the ThermalTherapy Pad 800 from the Cold Tank 801. A temperature of a return fluidfrom the Thermal Therapy Pad 800 may be measured via the temperaturesensor 810. If the temperature measurement is above a thresholdtemperature specification, the return fluid is directed via actuation ofthe solenoid 809 to the Hot Tank 802. As the return thermal fluid isreduced to a Cold Cycle threshold temperature, the return thermal fluidis directed via activation of the valve 809 back to the Cold Tank 801.

In preferred embodiments, thermal fluid is maintained in a respectivereservoir in both the Hot Tank and the Cold Tank. The thermal fluid maybe in thermal communication with a thermoelectric device 805 and broughtto a controlled temperature via thermal communication with a Peltierdevice. In other embodiments, a heater element or other heatingmechanism or a cooling compressor or other cooling device may be inthermal communication with the thermal fluid contained in the respectivereservoirs. Direction of the return fluid to either of the Heated FluidReservoir in the Hot tank 804 and the Cold Fluid Reservoir in the ColdTank 803 may be accomplished after a timed delay (such as, for example,10 or more seconds) or after the return fluid reaches a programmed orpredetermined threshold temperature. Predetermination may beaccomplished, for example via an electronic thermocouple in logicalcommunication with the valve 809, a mechanical thermostat actuated via athermal spring, or other temperature actuated device.

Referring now to FIG. 8D, a detailed view of exemplary embodiments ofthe higher level representations of FIGS. 8A-8C is illustrated. A ColdTank 801 and a Hot Tank 802 are shown, each in fluid communication witha Thermal Therapy Pad 800. The fluid communication enables thermalcommunication via the transport of thermal fluids 826 and 827 throughvarious components of a fluid conveyance system, including fluid lines825; pumps 811-812; solenoid valves 821-824; heat exchangers 818 and 828and the like.

Cold pump 811 is always active. During a cold cycle fluid from this pumpis included in a thermal therapy protocol specifying a temperature rangeand duration of thermal conditions applied via the thermal therapy pad800 that are generally cooler than a specified hot cycle. During atransition period from a cold cycle to a hot cycle and during a hotcycle the cold pump 811 circulates fluid through the cold HX back to thecold tank keeping the cold fluid cold for the next cold cycle During thetransition period from hot to cold, the cold pump pushes hot fluid fromthe pad 800 back to the hot tank.

Similarly, hot pump 812 is always active. During a hot cycle fluid fromthis pump is included in a thermal therapy protocol specifying atemperature range and duration of thermal conditions applied via thethermal therapy pad 800 that are generally hotter than a specified coldcycle. During a transition period from a hot cycle to a cold cycle andduring a cold cycle the hot pump 811 circulates fluid through the hottank/immersion heater 828 keeping the hot fluid hot for the next hotcycle During the transition period from cold to hot, the hot pump pushescold fluid from the pad 800 back to the cold tank

Solenoid valves 821-824 are operative to direct a flow of thermal fluidbased upon a thermal therapy protocol. The thermal therapy protocolspecifies a thermal condition to be experienced by a patient viaconditions in the thermal therapy pad 800. The thermal condition mayinclude a temperature for a period of time. Time instance may be trackedalong a therapy time continuum that commences as a therapy sessionbegins. Time instances included in the therapy time continuum may beassociated with specific temperature and pressure to be experienced bythe patient at a specific time instance. Solenoid included in thesolenoid valves 821-824 may be activated to cause the conditionsspecified at a time instance to be experienced by the patient.Conditions experienced by the patient may include a rapid transition ofthermal energy from one time instance to another based upon the methodsand apparatus discussed herein, including a return of fluid 826-827present in the thermal therapy pad 800 to a thermal fluid tank 801-802supplying thermal fluid 826-827 prior to the rapid transition of thermalenergy specified in a treatment protocol (or specified by a manual usercommand), until the transition in thermal energy has been accomplished(or a specified percentage of thermal energy transition has beenaccomplished, such as 80% or 90% of the thermal energy transition).

In some embodiments, an immersion heater 828 or other heating elementmay heat thermal fluid 827 in the Hot Tank 802. The immersion heater 828may also be placed in the hot fluid line after the hot pump 812. Otherheating means, such as a TE heat exchanger may also be used.

In some embodiments, a heat exchanger 818 may be used to change atemperature of thermal fluid 826-827. The heat exchanger may include oneor more thermoelectric modules placed in thermal communication with thethermal fluid. The functioning of a thermoelectric heat exchanger allowsit to be operative to change a temperature of the thermal fluid 826-27to a hotter or cooler temperature within a very accurate tolerance.

Thermistors 813-815 may quantify a temperature of thermal fluid atvarious positions within the fluid communication channels 800-802,811-818, 821-825 within the thermal therapy system 830. A user interface819-820 may include a status of one or more conditions within thethermal therapy system 830, such as, for example, a level of fluidwithin the Cold Tank 801 and/or the Hot Tank 802. In some embodiments,the user interface 819-820 may be a visual window into a thermal fluid826-827 level.

In addition, a Cold RTD 816 and a Hot RTD 817 are typically used tocontrol the cold and hot fluid temperatures respectively. RTD's arepreferred due to their long term stability.

Some embodiments may include an integrated sterilizer 829 to sterilizethermal fluid 826-827 and/or one or more aspects of the thermal therapysystem 820. Sterilization may be accomplished by sterilizer 829 viaexposure to ultraviolet light, chemical methods, ozone or other reactivegas, and/or a filter. Sterilization may be added to existing units byinserting a sterilizer in a fluid circulation loop, e.g., hot line 209 band/or cold line 210 b.

Referring now to FIG. 10A, a graph 1000A quantifies respectivetemperatures 1005A of a Cold Tank 1001A and a Hot Tank 1002A duringprogression of a thermal therapy protocol including specified thermalpad temperatures 1003A along a time continuum 1004A. Of significance isthe minimal variance of temperature following a transition of thermalpad temperature 1003A, such as those transitions that occur, forexample, at time 20 seconds; time 140 seconds; time 260 seconds; andtime 380 seconds. The minimal delta in tank temperatures 1001A-1002A inthe graph 1000A result from time delayed mitigation. Similar results andsometimes better results are experienced from a transition based upon atemperature of thermal fluid returning to the tanks.

Referring now to FIG. 11, a graph quantifies a stableness of temperature1108 of a Cold Tank 1101 and a Hot Tank 1102 over a continuum of time1107 during which a thermal therapy protocol 1106 is administered. Thegraph 100 also indicates a temperature of fluid returning from thethermal therapy pad 1103 following circulation through a thermal therapypad positioned on a body part portion (in this case, a thermal therapypad wrapped around a human leg). A percentage of heating capacity 1104and a percentage of cooling capacity 1105 is also indicated on thegraph.

Referring now to FIGS. 9A-9D, multiple various views of a thermal fluidreservoir unit 900 are illustrated. According to the present invention,a thermal fluid reservoir unit 900 may include both a Hot FluidReservoir 902 and a Cold Fluid Reservoir 903. The Hot Fluid Reservoir902 and a Cold Fluid Reservoir 903 may both be filled via a singlefilling spout 901. Accordingly, thermal fluid 904 may be poured, orotherwise provided to, the single filling spout 901 and then diverted toone or both of the hot fluid reservoir 902 and the cold fluid reservoir.A tank dividing wall 907 may separate the Hot Fluid Reservoir 902 and aCold Fluid Reservoir 903. The tank dividing wall 907 may comprise athermal insulating material and or be shaped to provide a air gapbetween the Hot Fluid Reservoir 902 and a Cold Fluid Reservoir 903.

Thermal fluid 904 in the thermal fluid reservoir unit 900 may naturallyflow from one of the Hot Fluid Reservoir 902 and a Cold Fluid Reservoir903 to the other upon reaching a level 908 equal to a top of the tankdividing wall 907. Thermal fluid within the thermal fluid reservoir unit900 will therefore self-equilibrate and prevent overflowing of one ofthe Hot Fluid Reservoir 902 and a Cold Fluid Reservoir 903 while theother reservoir is less than full of thermal fluid. One or more firstfluid ports 905 may be functional as an egress for thermal fluid 904 andtherefore be functional to transport fluid out of the thermal fluidreservoir unit 900. One or more second fluid ports 906 may be functionalas an ingress for thermal fluid 904 and therefore be functional totransport fluid into the thermal fluid reservoir unit 900.Alternatively, two separate fluid reservoirs with separate fill portsmay be used.

Various embodiments may include multiple wraps specific to fluidchannel/pump configurations. For example, after a baseball game (orduring portions of the game that the pitcher is not active pitching,e.g., portions of an inning that the pitcher's team is at bat), apitcher may have a first wrap on a pitching arm, and a second wrap on aleg.

Some embodiments may include multiple fluid loops within a single wrap,each fluid loop may have separately controlled pressure and/ortemperature. In particular, wrap may be designed with specific areas ofhigh/low pressure and high/low heat/cold. Control of individualspecified areas of wrap, designs may include areas of heat in oneportion of wrap and cold in another portion; areas of pressure in onearea and areas of relief in another. For example, a single wrap aroundthe upper arm may include a first pressure loop to provide a firstamount of pressure and temperature therapy the bicep muscles, and asecond pressure loop to provide a second amount of pressure andtemperature therapy to triceps muscles.

Embodiments may include lines from a TEC unit to a thermal therapy wrapthat includes both fluid channels and data conduits. Likewise, someembodiments may include pre-programmed thermal and/or pressure cycles ona per patient basis with patient identification, e.g., a finger scan orother biometric identifier (ID). In particular, therapy cycles may becontrolled with respect to temperature profiles, pressure profiles,feedback loop and adjustment of individual specific aspects (e.g. pumps,valves, TEC unit) during therapy cycles, and compliance record of actualtherapy applied.

Further, some embodiments may record location, time, date, and/orduration of therapy on a per patient basis with patient identification,e.g., a finger scan, biometric ID, unique identifier, etc. Specificembodiments may include control by use of a smart device (e.g., iPhone®or Android™ phone, tablet, etc.), and transmission to a data aggregator.In particular, embodiments may include aggregating data across multiplepatients, location, age etc. Embodiments also may include remote controlof therapy (e.g., therapy cycle profile being inputted by a practitionerfrom a remote site), and managing a universally unique identifier (UUID)of a therapeutic device.

Still further, some embodiments may include hot and/or cold temperatureprofiles according to a desired treatment plan on a per-patient basiswith patient identification, e.g., finger scan, other biometric ID,unique identifier etc. In particular, profiles may include a therapyprofile for injury, a profile to increase performance during sidelinebreaks of athletic performance, a profile to increase cognitive ability,and/or a profile to increase blood circulation during long sedentaryperiods, e.g., during airplane travel, sitting at a desk, laying in ahospital bed, etc.

Embodiments may combine temperature and/or pressure therapy with lighttherapy. In particular, light therapy may be applied in coordinationwith a thermal/pressure cycle, and/or to complement the objective of athermal/pressure cycle. For example, a thermal/pressure cycle that heatsand causes vasodilation may be complemented with light that also causesvasodilation, or the light may be removed during constriction thermalcycle, etc. Light therapy may increase adenosine triphosphate (ATP)production in synchrony with thermal cycle and/or pressure cycle. Lighttherapy may be applied at infrared, e.g., about 660-980 nanometer.

Embodiments may include magnetic application, and may be included in thethermal fluid being circulated. Light or magnetic therapy may be alignedwith acupressure and/or acupuncture locations. The location of light ormagnetic therapy may be detailed on a sleeve. The sleeve may be specificto a patient, so that a practitioner may mark a location of atherapeutic agent on a sleeve, and then therapy is applied according tothe markings.

Some embodiments may include a therapeutic profile based upon biometricreadings of a patient. This feature may be tied to activation ofspecific pumps, valves, etc. Parameters to monitor may include pulserate, blood pressure, swelling, skin temperature, body temperature,temperature differential between skin and core body, and so forth.

In another aspect, multiple wraps on a single patient may beadministered at once with a single TEC machine. The hydraulic andphysical interface may be configured in parallel with “Y” fittings tocirculate, and/or a manifold with separate on/off valves. Embodimentsmay include automatic control of valves. Alternatively, the hydraulicand physical interface may be configured to be serial, using fittings toextend a flow, e.g., to an ankle, a lower leg, an upper leg, a torso, ashoulder an arm, etc. Alternatively, an attachment mechanism may coupleone pump to the next. The hydraulic and physical interface may includefluid communication, and physical fasteners such as a hook and loopfastener (i.e., Velcro™), snaps, etc.

Embodiments may include multiple patients treated with a single largeTEC machine, in order to provide efficiency of scale, wherein onepatient may receive cooling therapy while another patient simultaneouslymay receive heating therapy. When it is time for the temperature cycleto reverse, a valve may switch to change fluid flow.

Multiple patients may be treated in parallel, such that a control unitturns flow on or off to an individual patient or individual treatmentarea (or limited/fully open) depending upon conditions measured atindividual patient or treatment area.

Embodiments may combine thermal, pressure, and light with pharmaceuticaltreatment. Synergistic benefits may include treatment timing (i.e.,synchronization), coordinated dosage and duration. Embodiments takeadvantage of capillary constriction and dilation based upon thermaltreatment. Treatments may be by topical application (i.e., transdermalbased upon treatment site), or injection at site of therapy. Embodimentsinclude treatment protocols based upon drug response to thermal,pressure, and light conditions, for example, a heat or light activateddrug.

Embodiments may include topical gel or cream, in conjunction withoptimized thermal, magnetic, and/or light transfer therapy. Embodimentsmay include pain relief, e.g., anesthesia such as lidocaine to reducelocalized pain. Embodiments may include a therapeutic agent. Embodimentsmay include cleaning and germ treatment to preserve sterile integrity ofequipment.

Embodiments combine contrast therapy with movement (i.e., physicaltherapy (PT)), which may include treatment before and/or after PT.Embodiments include tracking movement (e.g., accelerometer or imagetracking), and matching movement and thermal application. Embodimentsmay record movement, biometrics, thermal condition, pressure, and/orother treatments as well as time, place, and patient, etc.

Embodiments may also include contrast therapy pad with Thermal electrictiles on a pad. For example, TEC tiles may be controlled individually oronly in pre-defined areas. Fluid channels may be used to disperse excessheat or cold. In this case, fluid is needed only to add or remove heat,not to supply therapeutic temperature, and benefits may include lessfluid required. Temperature sensors in the pad would be required in thisembodiment. Embodiments may be associated with reservoirs of heatedfluid and/or cooled fluid. These embodiments may be more efficient andprovide a faster temperature transition. A gel and/or liner material orgel pack may be used to enhance the transfer of heat from the pad to theskin.

Embodiments may include a smart device controller for a TEC unit.Embodiments may display specific conditions pre-programmed in the TECunit, and display conditions of treated area (e.g., pressure,temperature). Embodiments allow for remote monitoring of actualconditions. Embodiments are not limited to thermowraps, but instead maybe applicable to other TEC devices. Embodiments may gather data in localdata form, convert the data to Internet Protocol (IP) messages, transmitthe IP messages to a remote monitoring station or server, and at theremote monitoring station or server convert the IP messages back todisplay format for displaying to a person, Embodiments may recordtime/place, may perform remote monitoring of status, and may monitorcompliance with a treatment protocol.

Embodiments may provide data aggregation (big data) across multipletreatments and profiles. Big data is known in the art as extremely largedata sets that may be analyzed computationally to reveal patterns,trends, and associations, especially relating to human behavior andinteractions. As applied to therapy, big data aggregation may helpidentify beneficial treatment regimes.

Embodiments may be combined with physical therapy motion monitoring,e.g., motion monitoring of a limb, while the patient is upright,reclined, or supine. Embodiments may monitor compliance with a therapyprotocol, and may allow the compliance to be viewed remotely, e.g., by ahealth care provider or by the patient.

Referring now to FIG. 12, another aspect of the present inventionincludes methods for purging a thermal therapy wrap 1214 of thermalfluid for storage while the thermal therapy pad 1214 is not in use.

After strenuous exercise or after injury/surgery, thermal therapyinvolving application of contrasting heating and cooling to mammaliantissue, may be implemented to speed recovery. The present inventionincludes multiple methods and apparatus for accomplishing such thermaltherapy using a wrap containing fluid channels through which a hot orcold fluid is pumped. These methods allows precise control of thetherapy temperature, providing superior results.

When a thermal therapy treatment is completed a thermal therapy wraptypically contains a significant quantity of thermal fluid. It isdesirable to remove this fluid prior to storing the wrap. Removal of thethermal fluid from the thermal therapy wrap allows for ease of storageand substantially reduces the thermal therapy pad's weight. One aspectof the present invention provides a novel way to remove this fluid, amethod that does not require the use of compressed air or vacuumapparatus, but instead uses the pump that conveys thermal fluid to thethermal therapy wrap during a thermal therapy procedure to be used toalso remove fluid from the wrap prior to its storage.

As discussed herein, in some exemplary embodiments, a thermal therapyprotocol may include multiple thermal therapy procedures or methodsteps. During a thermal therapy method step of procedure (either heatingor cooling) fluid flows from Reservoir 1204 to Pump 1206 through thermalfluid channel (such as a tube) 1205. Pump 1206 pumps the fluid into heatexchanger 1207 through a Tube 1208 to open Solenoid Valve 1210 and thento the Thermal Therapy wrap 1214. From the Therapy wrap 1214 the fluidreturns to the Reservoir 1204 via return Tube 1201 and Venturi Tee 1202.

When a thermal therapy method step or protocol procedure is complete,Solenoid Valve 1210 may close and Solenoid Valve 1209 may open, causingfluid to flow through Venturi Nozzle 1203. Venturi Nozzle 1203 causeshigh velocity fluid to flow through Venturi TEE 1202, creating anegative suction pressure in return tube 1201 which in turn pull fluidout of Wrap 1214.

If Reservoir 1204 is not vented, then air line 1211 from the air spaceabove the Reservoir 1204 may, for example be connected to a Wrap 1204supply tube 1211 through a Check Valve 1213 to allow fluid returning toReservoir 1204 to displace the air in space 1215. The Check Valve 1213is thereby operative to prevent fluid from by-passing the Wrap 1214during the thermal therapy method step or procedure and flowing directlyback to the Reservoir 1204.

A number of embodiments of the present invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention. Forexample, various methods or equipment may be used to implement theprocess steps described herein or to create a device according to theinventive concepts provided above and further described in the claims.In addition, various integration of components, as well as software andfirmware may be implemented. Accordingly, other embodiments are withinthe scope of the following claims.

While the foregoing is directed to embodiments of the presentdisclosure, other and further embodiments of the present disclosure maybe devised without departing from the basic scope thereof. It isunderstood that various embodiments described herein may be utilized incombination with any other embodiment described, without departing fromthe scope contained herein. Further, the foregoing description is notintended to be exhaustive or to limit the disclosure to the precise formdisclosed. Modifications and variations are possible in light of theabove teachings or may be acquired from practice of the disclosure.Certain exemplary embodiments may be identified by use of an open-endedlist that includes wording to indicate that the list items arerepresentative of the embodiments and that the list is not intended torepresent a closed list exclusive of further embodiments. Such wordingmay include “e.g.,” “etc.,” “such as,” “for example,” “and so forth,”“and the like,” etc., and other wording as will be apparent from thesurrounding context.

No element, act, or instruction used in the description of the presentapplication should be construed as critical or essential to thedisclosure unless explicitly described as such. Also, as used herein,the article “a” is intended to include one or more items. Where only oneitem is intended, the term “one” or similar language is used. Further,the terms “any of” followed by a listing of a plurality of items and/ora plurality of categories of items, as used herein, are intended toinclude “any of,” “any combination of,” “any multiple of,” and/or “anycombination of” multiples of the items and/or the categories of items,individually or in conjunction with other items and/or other categoriesof items.

Moreover, the claims should not be read as limited to the describedorder or elements unless stated to that effect. In addition, use of theterm “means” in any claim is intended to invoke 35 U.S.C. § 112(f), andany claim without the word “means” is not so intended.

What is claimed is:
 1. A contrast therapy apparatus to providecontrolled therapeutic treatments, comprising: a thermal pad,comprising: a fluidic channel having an input port and an output port;and a thermally-transmissive outer covering; and a control unit,comprising: a fluid channel output port coupled to the input port of thethermal pad fluidic channel; a fluid channel input port coupled to theoutput port of the thermal pad fluidic channel; one or both of ahot-fluid circulation loop coupled to the output port and the input portand a cold-fluid circulation loop coupled to the output port and theinput port; a pump to provide fluid flow in at least one of thehot-fluid circulation loop and the cold-fluid circulation loop; aprocessor coupled to a memory, the processor configured to executeinstructions stored in the memory, to provide to the thermal pad a fluidflow having a predetermined temperature profile; one or more divertingvalves operative to cause the hot fluid to flow out of the hot reservoirand into the thermal pad, and flow out of the thermal pad into a coldfluid reservoir during a cold to hot transition delay period, and thehot fluid to flow out of the hot reservoir and into the thermal pad, andflow out of the thermal pad into the hot fluid reservoir during a hotcycle that follows the cold to hot transition delay period; and asolenoid valve at each end of therapy pad, the valves operative todivert fluid from flowing into the input port of the thermal pad toflowing to a Venturi that provides suction pressure to remove fluid fromthe wrap.
 2. The contrast therapy apparatus of claim 1, furthercomprising separate pumps for the hot-fluid circulation loop and thecold-fluid circulation loop.
 3. The contrast therapy apparatus of claim1, wherein the one or more diverting valves comprise one or more hotvalves to couple the hot-fluid circulation loop to the therapy pad andone or more cold valves to couple the cold-fluid circulation loop to thetherapy pad, said one or more hot valves and one or more cold valvesoperative to cause the cold fluid to flow out of the cold reservoir andinto the thermal pad, and flow out of the thermal pad into the hot fluidreservoir during a hot to cold transition delay period, and the coldfluid to flow out of the cold reservoir and into the thermal pad, andflow out of the thermal pad into the cold fluid reservoir during a coldthermal cycle which follows the hot to cold transition delay period. 4.The contrast therapy apparatus of claim 1 wherein a flow of hot fluidout of the hot reservoir and into the thermal pad, and flow out of thethermal pad into the cold fluid reservoir during the cold to hottransition delay period improves stability of the hot fluid reservoirduring a hot thermal cycle by reducing a change of temperature change inthe hot fluid tank as compared to a change in a temperature in the hotfluid tank without a transition delay period comprising returning fluidfrom the hot fluid tank into the cold fluid reservoir.
 5. The contrasttherapy apparatus of claim 3 wherein a flow of cold fluid out of thecold reservoir and into the thermal pad, and flow out of the thermal padinto the hot fluid reservoir during the hot to cold transition delayperiod improves the stability of the cold fluid reservoir during a coldthermal cycle by reducing a change of temperature change in the coldfluid reservoir as compared to a change in temperature in the cold fluidreservoir without a transition delay period comprising returning fluidfrom the cold fluid reservoir into the hot fluid reservoir.
 6. Thecontrast therapy apparatus of claim 3 wherein one or both of the hot tocold transition delay period and the cold to hot transition delay periodis based upon a type of thermal pad through which fluid is circulated.7. The contrast therapy apparatus of claim 5 wherein one or both of thehot to cold transition delay period and the cold to hot transition delayperiod is based upon a size of the thermal pad.
 8. The contrast therapyapparatus of claim 7 where one or more of the hot to cold transitiondelay period or the cold to hot transition delay period comprisesbetween 5 seconds and 90 seconds.
 9. The contrast therapy apparatus ofclaim 8 where one or more of the hot to cold transition delay period orthe cold to hot transition delay period comprises between 15 seconds and40 seconds.
 10. The contrast therapy apparatus of claim 8 wherein a flowrate of fluid through the thermal pad comprises between about 0.5 to 2liters per minute.
 11. The contrast therapy apparatus of claim 8 whereina flow rate of fluid through the thermal pad comprises between about 0.8and 1.2 liters per minute.
 12. The contrast therapy apparatus of claim 8additionally comprising a temperature sensor measuring a temperature offluid in one or both of the hot-fluid circulation loop and thecold-fluid circulation loop.
 13. The contrast therapy apparatus of claim12 wherein one or more of the hot to cold transition delay time or thecold to hot transition delay time is determined by measuring a returningfluid temperature with the temperature sensor and actuating return sidediverting valves when the measured return side temperature reaches apre-determined threshold.
 14. The contrast therapy apparatus of claim 12wherein the pre-determined threshold occurs when return side temperaturechanges in an amount of between about 2° C. and 20° C. from a normalreturn side treatment temperature.
 15. The contrast therapy apparatus ofclaim 12 wherein the pre-determined threshold occurs when return sidetemperature changes in an amount of between about 7° C. and 13° C. froma normal return side treatment temperature.
 16. The contrast therapyapparatus of claim 12 wherein one or both of the hot to cold transitiondelay period or the cold to hot transition delay period is determined bymeasuring a temperature of returning fluid with the temperature sensorand actuating return side diverting valves when the measured return sidetemperature change meets a pre-determined rate of change.
 17. Thecontrast therapy apparatus of claim 15 wherein the pre-determined rateof change is between about 0.01° C./sec and 0.2° C./sec.
 18. Thecontrast therapy apparatus of claim 15 wherein the pre-determined rateof change is between about 0.01° C./sec and 2.0° C./sec.
 19. Thecontrast therapy apparatus of claim 15 wherein the pre-determined rateof change is between about 0.5° C./sec and 1.5° C./sec.
 20. The contrasttherapy apparatus of claim 1 additionally comprising tubing attached toeach valve, the tubing size comprising a ¼″ inside diameter and a flowrate through the venturi is between about 1 liters per minute and 2liters per minute.